MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM - FEMORAL; VENA CAVA FILTER

BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM - FEMORAL; VENA CAVA FILTER

Catalog Number MD800F

Device Problems Occlusion Within Device (1423); Difficult to Remove (1528); Obstruction of Flow (2423); Malposition of Device (2616)

Patient Problems Death (1802); Edema (1820); Thrombus (2101)

Event Date 04/28/2013

Event Type Death

Manufacturer Narrative

No medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.Medical records were received and reviewed and the investigation of the reported event is currently underway.Medical records review: the patient with deep venous thrombosis was scheduled for placement of an inferior vena cava (ivc) filter.The right femoral vein was accessed and an inferior venacavogram demonstrated no evidence of intraluminal filling defects.The ivc was normal in size and caliber without evidence of duplication.The filter was then deployed in an appropriate position in the ivc without incident.The patient tolerated the procedure well.Approximately two months post filter deployment, ct imaging performed to rule out pulmonary embolism demonstrated no evidence of pulmonary thromboembolism; however, a 4 x 1 cm posterior eccentric intraluminal filling defect in the distal superior vena cava (svc) suggestive of an embolus was identified.Approximately two years one month post filter deployment, ct imaging demonstrated resolution of the filling defect in the distal svc, and noted the filter in place.Approximately two years six months post filter deployment, ct imaging demonstrated the filter in the infrarenal position and the ivc caudal to the filter was diminished in size with a diameter of approximately 5 mm.Approximately three years post filter deployment, the patient was assessed to have chronic bilateral lower extremity edema due to the filter that was malpositioned and occluded and was scheduled for consultation and removal of the filter.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.Investigation summary: the device was not returned for evaluation and images were not provided for review.However, medical records were provided and reviewed.Approximately two months post filter deployment, ct imaging performed to rule out pulmonary embolism demonstrated no evidence of pulmonary thromboembolism; however, a 4 x 1 cm posterior eccentric intraluminal filling defect in the distal superior vena cava (svc) suggestive of an embolus was identified.Approximately three years post filter deployment, the patient was assessed to have chronic bilateral lower extremity edema due to a malpositioned filter that was occluded and was scheduled for consultation and removal of the filter.No further information was provided in the medical records confirming that the filter was tilted or occluded or how the assessment was made.It is also unknown if the filter was removed.Therefore, the investigation is inconclusive for the alleged malpositioned filter and occlusion within the filter.It can be confirmed that the patient experienced thrombus above the filter after filter implantation, however the origin of the thrombus is unknown and the relationship to the filter has not been established in the provided medical records.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/potential complications movement, migration or tilt of the filter are known complications of vena cava filters.Filter malposition, caval thrombosis/occlusion.Note: it is possible that complications such as those described in the "warnings", "precautions," or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted.

Event Description

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.Investigation summary: the device was not returned for evaluation and images were not provided for review.However, medical records were provided and reviewed.Approximately two months post filter deployment, ct imaging performed to rule out pulmonary embolism demonstrated no evidence of pulmonary thromboembolism; however, a 4 x 1 cm posterior eccentric intraluminal filling defect in the distal superior vena cava (svc) suggestive of an embolus was identified.Approximately three years post filter deployment, the patient was assessed to have chronic bilateral lower extremity edema due to a malpositioned filter that was occluded and was scheduled for consultation and removal of the filter.No further information was provided in the medical records confirming that the filter was tilted or occluded or how the assessment was made.It is also unknown if the filter was removed.Therefore, the investigation is inconclusive for the alleged malpositioned filter and occlusion within the filter.It can be confirmed that the patient experienced thrombus above the filter after filter implantation, however the origin of the thrombus is unknown and the relationship to the filter has not been established in the provided medical records.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.

Event Description

It was reported that a vena cava filter was successfully deployed for a history of deep vein thrombosis.Approximately two months post filter deployment, ct imaging demonstrated thrombus above the filter.Approximately three years post filter deployment, it was indicated that the patient had chronic bilateral lower extremity edema due to the malpositioned and occluded filter.The patient was scheduled for consultation regarding removal of the filter.New information: it was reported through the litigation process that some time post vena cava filter deployment (date not provided) the patient expired.There was no specific device malfunction reported that may or may not have caused or contributed to the patient¿s death.The cause of the patient¿s death was not provided.No other pertinent patient, device or medical information was provided leading up to or surrounding the event.

Manufacturer Narrative

Event Description

Manufacturer Narrative

Event Description

It was reported that a vena cava filter was successfully deployed for a history of deep vein thrombosis.Approximately two months post filter deployment, ct imaging demonstrated thrombus above the filter.Approximately three years post filter deployment, it was indicated that the patient had chronic bilateral lower extremity edema due to the malpositioned and occluded filter.The patient was scheduled for consultation regarding removal of the filter.It was reported through the litigation process that some time post vena cava filter deployment (date not provided) the patient expired.There was no specific device malfunction reported that may or may not have caused or contributed to the patient¿s death.The cause of the patient¿s death was not provided.No other pertinent patient, device or medical information was provided leading up to or surrounding the event.It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter tilted and embedded in the wall of ivc.The device was removed percutaneously.The patient reportedly expired.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with left lower extremity deep vein thrombosis and pulmonary emboli.At some time post filter deployment, it was alleged that the filter was difficult to remove, filter tilted and embedded in the wall of the inferior vena cava.The device was removed percutaneously.The patient was diagnosed with thrombus above the filter and had chronic bilateral lower extremity edema due to the malpositioned and occluded filter.The patient reportedly expired.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately nine months and eighteen days later, computed tomography (ct) revealed that an inferior vena cava filter was present.On the same day, an arterial duplex lower extremity bilateral showed incidental left common femoral vein deep vein thrombosis.Also, a venous bilateral extremity study with doppler showed positive for extensive deep venous thrombosis of bilateral lower extremities.Subsequently two days later, the patient underwent deep vein thrombolysis of right leg.Approximately seven months and nine days later, non-invasive vascular laboratory venous duplex lower extremity right showed extensive deep vein thrombosis, seen from common femoral vein, superficial femoral vein, and right popliteal vein with nearly occlusive echogenic structure/thrombus.Approximately three months and two days later, ultrasound lower extremity venous duplex bilateral showed bilateral non-occlusive thrombus within the proximal right common femoral vein.Occlusive thrombus was noted within the right popliteal vein.There was non-occlusive thrombus within the left common femoral vein, that extended to the distal superficial femoral vein.Also, a computed tomography angiography (cta) revealed that there was no filling defect to confirm pulmonary embolism.On the next day, computed tomography (ct) revealed that an inferior vena cava filter was in place.Approximately four months and twenty-eight days later, computed tomography angiography (cta) showed no evidence of pulmonary embolism.Approximately two weeks and two days later, venous duplex bilateral lower extremities revealed that there was no evidence of deep vein thrombosis on the right lower extremity and presence of partial thrombus within the left common femoral vein.Subsequently eight days later, computed tomography (ct) revealed that an inferior vena cava filter was again noted.There was resolution of filling defect in distal superior vena cava, consistent with resolution of small embolus.Approximately two months and eleven days later, computed tomography angiography (cta) chest showed negative for pulmonary embolism.Also, an ultrasound bilateral lower extremity venous duplex showed that non-occlusive deep vein thrombosis was present in the right common femoral vein.Previously described thrombus within the right popliteal vein was no longer identified.Non-occlusive deep vein thrombosis was present in the left common femoral vein.Subsequently one month and nine days later, the patient experienced pain and on the same day, an abdomen complete with one view chest showed that there was no suspect calcification or radiopaque foreign body.Approximately two weeks and six days later, computed tomography (ct) revealed that an inferior vena cava filter was seen in the infrarenal position.Subsequently one week and five days later, x-ray revealed that an inferior vena cava filter was noted.Approximately five months and seventeen days later, computed tomography (ct) revealed that meridian inferior vena cava filter was noted in place, with tip along the posterior wall.The filter was complicated by chronic total occlusion of the infrarenal inferior vena cava, bilateral common iliac veins and left external iliac vein.Approximately three weeks and one day later, the patient was diagnosed with chronic inferior vena cava filter occlusion.Approximately two weeks and four days later, the patient¿s discharge summary stated that the inferior vena cava filter was found to be malpositioned.Approximately eleven months and nine days later, an attempt was made to retrieve the chronically embedded bard meridian inferior vena cava filter complicated by total occlusion of the infrarenal inferior vena cava, bilateral iliac veins and left external iliac vein.An ultrasound of the bilateral groins demonstrated that there was chronic non-occlusive thrombus in the left common femoral vein.Spot radiograph of the abdomen demonstrated a bard meridian filter.The filter was at the level of l3-l4 with the hook directed towards the patient¿s left.There was no apparent fracture.Fluoroscopic images demonstrated that the inferior vena cava filter was intact.The right internal jugular vein was accessed using a micropuncture set.A 12 mm x 6 cm atlas balloon was used to predilate the inferior vena cava, right common iliac vein and right external iliac vein.The sheath was advanced just below the apex of the filter.Rigid forceps were placed through the sheath.The embedded apex was gently dissected free from the caval wall and then engaged by the forceps.The sheath was successfully advanced over the filter apex and the apex was captured with a trilobed snare.The entire filter was able to be over sheathed with gentle traction.Then, smart stents were placed in the left common iliac vein, left external iliac vein and right common iliac vein.All sheaths and wires were removed, and the patient tolerated the procedure well, and there were no immediate complications.Therefore the investigation is confirmed for filter malposition and occlusion of the inferior vena cava filter.However, the investigation is inconclusive for retrieval difficulties and thrombus above the filter.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.(expiry date: 11/2013).

Search Alerts/Recalls

New Search | Submit an Adverse Event Report

Brand Name

MERIDIAN FILTER SYSTEM - FEMORAL

Type of Device

VENA CAVA FILTER

Manufacturer (Section D)

BARD PERIPHERAL VASCULAR, INC.

1625 w 3rd st.

tempe AZ 85281

MDR Report Key

6836844

MDR Text Key

84303533

Report Number

2020394-2017-01070

Device Sequence Number

Product Code

DTK

Combination Product (y/n)

PMA/PMN Number

K112497

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

consumer,health professional

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

08/31/2017

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Yes

Device Operator

Health Professional

Device Expiration Date

11/30/2013

Device Catalogue Number

MD800F

Device Lot Number

GFWJ1341

Was Device Available for Evaluation?

Date Manufacturer Received

12/10/2020

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Treatment

AVODART, CLONIDINE, LANTUS, LISINOPRIL, FLOMAX.; AVODART, CLONIDINE, LANTUS, LISINOPRIL, FLOMAX.; AVODART, CLONIDINE, LANTUS, LISINOPRIL, FLOMAX.; AVODART, CLONIDINE, LANTUS, LISINOPRIL, FLOMAX.; AVODART, CLONIDINE, LANTUS, LISINOPRIL, FLOMAX.; AVODART, XARELTO, DILAUDID, KLONOPIN AND SEROQUEL.; CARDIZEM, K-DUR, TYLENOL, ZOFRAN AND DULCOLAX.; CEFTRIAXONE, NITROSTAT AND KEFLEX.; ENULOSE, PERI-COLACE, AMIODARONE AND LIPITOR.; LEVAQUIN, LISPRO, LANOXIN, LASIX AND OXYCODONE.; LOPRESSOR, NICOTINE, NORCO AND PRAVASTATIN.; METFORMIN, METOPROLOL, PRAVASTATIN, RIVAROXABAN.; METFORMIN, METOPROLOL, PRAVASTATIN, RIVAROXABAN.; METFORMIN, METOPROLOL, PRAVASTATIN, RIVAROXABAN.; METFORMIN, METOPROLOL, PRAVASTATIN, RIVAROXABAN.; METFORMIN, METOPROLOL, PRAVASTATIN, RIVAROXABAN.; NEURONTIN, LISINOPRIL AND METFORMIN HYDROCHLORIDE.; OLANZAPINE, COREG, FLUOXETINE AND METOLAZONE.; PRADAXA, INVANZ, LOVENOX, CEPHALEXIN AND CLONIDINE.; PROTONIX, SPIRONOLACTONE AND VANCOMYCIN.; SUCRALFATE, FLOMAX, ASPIRIN AND HYDRALAZINE.; ZYVOX, ZOLOFT, MAGOX, AMBIEN AND BACTRIM-DS.

Patient Outcome(s)

Death; Other;

Patient Age

59 YR

Patient Weight

100

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM - FEMORAL; VENA CAVA FILTER

Links on this page:

Links on this page: